Gladiševina, Zečji trn Ononis spinosa (Fabaceae)
Gladiševina Ononis spinosa (Fabaceae)
Ononidis radix (Restharrow Root) JUNE 21, 2016
Restharow Ononidis radix Restharrow Root
Ononis spinosa L. Published 2015
25 March 2014, EMA/HMPC/138317/2013,
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Ononis spinosa L., radix
24 March 2014, EMA/HMPC/138316/2013,
Committee on Herbal Medicinal Products (HMPC):
Assessment report on Ononis spinosa L., radix
Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use)
Qualitative and quantitative composition
With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Ononis spinosa L., radix (Restharrow root)
i) Herbal substance
Not applicable.
ii) Herbal preparations
Comminuted herbal substance.
Pharmaceutical form
Comminuted herbal substance as herbal tea for oral use.
The pharmaceutical form should be described by the European Pharmacopoeia full standard term.
Mother tincture HAB 3a
Therapeutic indications
Traditional herbal medicinal product used to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
Posology and method of administration
Posology
Adolescents, adults and elderly
Herbal tea: 2 – 3 g of comminuted herbal substance in 150 ml of boiling water as a herbal infusion up to 3 – 4 times daily corresponding to the maximum daily dose of 12 g.
The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Duration of use
If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be
consulted.
Method of administration
Oral use.
Contraindications
Hypersensitivity to the active substance.
Conditions where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease).
Special warnings and precautions for use
The use in children under 12 years of age has not been established due to lack of adequate data.
To ensure an increase of the amount of urine, adequate fluid intake is required during the treatment.
If urinary tract complaints worsen and symptoms such as fever, dysuria, spasm, or blood in the urine occur during the use of medicinal product, a doctor or a qualified health care practitioner should be consulted.
Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not
been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No fertility data available.